National Institute of Neurological Disorders and Stroke (NINDS)

1. Therapeutics and Diagnostics Development for Neurological Disorders, including biomarker and diagnostic assays, therapeutics (drugs, biologics, and/or devices) for treatment of neurological disorders, and technologies/methodologies to deliver therapeutics to the nervous system.
2. Clinical and Rehabilitation Tools, including intraoperative technologies for neurosurgeons, rehabilitation devices and programs for neurological disorders, and brain monitoring systems
3. Technology and Tools, including technologies to image the nervous system, neural interfaces technologies, and tools for neuroscience research and drug development.
Within these research topics, the following research may require additional funds above the hard budget caps:
A. In vivo animal testing required for therapeutics and diagnostics development.
B. Drug and biologics preclinical discovery and development activities for regulatory submission, such as lead identification/optimization, preclinical efficacy testing, IND-enabling studies, and manufacturing for clinical trials.
C. Device preclinical discovery and development activities for regulatory submission, such as hardware prototyping, device/software verification, biocompatibility/sterilization testing, pre-clinical efficacy testing, large animal GLP safety testing, and preparing material/devices for human testing.
D. Clinical testing of therapeutics (drugs, devices, or biologics), diagnostics, clinical and rehabilitation tools (i.e. intraoperative technologies, rehabilitation devices and programs, and brain monitoring systems), and technologies for clinical research. This would include clinical research studies to test scientific hypothesis that are not feasible or practical to conduct in animal models but would inform a final device design.
E. In vivo animal testing of technologies for animal research and development of animal models for drug development and neuroscience research.
F. Research that requires special facilities to contain hazardous or infectious materials.

Agency: Department of Health and Human Services,Department of Health and Human Services